Birth Model vs DermaSensor

DermaSensor is rented by the month on a one-year device use agreement with a try-and-return option, and the vendor has no published price for an outright purchase. Its buyer is a primary care physician holding a lesion already judged suspicious in a patient 40 or older. FDA granted De Novo DEN230008 on January 12, 2024 for a software-aided adjunctive diagnostic device. The vendor's FAQ says it is not a screening tool and not the sole diagnostic criterion. The vendor reports 96% sensitivity and 97% negative predictive value for a "Monitor" result from the DERM-SUCCESS multi-reader study. Its multicenter DERM-ASSESS III study puts specificity at 33%. The FAQ says a dedicated CPT code has not been established and EHR integration is still to come.

DermaSensor takes a handheld spectroscopy reading of a skin lesion at the point of care. Birth Model is aimed at hospital labor and delivery units, where its staffing module forecasts census seven days out and raises ratio alerts tied to AWHONN guidance. A primary care office and a labor and delivery unit are separate purchases. The vendor states SOC 2 Type II and offers a demo and an ROI calculator in place of a price.